Gastropexy kit

ABSTRACT

A gastropexy kit includes a plurality of safety needle assemblies. Each safety needle assembly includes a needle and a stylus. A fastener is positioned in a distal end of the needle. The fastener is coupled to one end of the suture and a suture retention hub is coupled to an opposite end of the suture. The fastener is deployed in a patient&#39;s stomach via the needle and stylus which has a blunt distal end which extends through the needle to push the fastener out of the needle and to blunt the needle. The suture retention hub is positioned on a patient&#39;s skin and adjustably tensions the suture, which, desirably, is a resorbable suture.

BACKGROUND OF THE INVENTION

This invention relates to a gastropexy kit having at least one hollowneedle configured to hold a fastener. The fastener is held in a shaft ofa needle. The fastener desirably has a suture coupled thereto and, nearan opposite end, a suture holder, for use in a percutaneous fixation ofa patient's stomach.

Health care providers are at risk of exposure to blood-borne pathogens,including, for example, hepatitis B, hepatitis C, HIV, and the like. Therisk of an accidental stick from a sharp object, such as a needle,exists in many medical procedures. One such procedure is gastropexy, inwhich a needle is used to pierce a patient's abdominal wall to place oneor more fasteners in a patient's stomach. Such a needle must be sharp,so that it penetrates through the patent's skin and abdominal wall tothe stomach. A fastener, such as a “T-bar” fastener, carried at or nearthe tip of the needle is desirably deployed by the needle so that it canbe positioned against an inner wall of the stomach. A tensioning sutureis connected to the fastener and, at an opposite end of the suture onthe outer surface of the patient's body, the suture is desirably alsoconnected to a suture holder, which permits adjustment of the tension onthe suture. In this manner, when the suture is tensioned a patient'sstomach wall is more closely positioned to the outer surface of thepatient's body, and the stomach is stabilized in a position. Usually, atleast three and desirably four fasteners are placed in a triangular,square, or diamond-shaped configuration through a patient's skin andinto the stomach. Gastropexy is used to isolate and stabilize a portionof a patient's stomach, so that a tissue opening or stoma may be createdin the middle of the triangular, square or diamond configuration offasteners and suture holders, to permit placement of a feeding tube, andso forth.

After each fastener is positioned by a needle, the needle still remainsas a sharp hazard, in its position inside of the patient's stomach, aswell as when it is removed therefrom. Therefore, there is a need toprovide an apparatus which permits blunting of the needle after thefastener is deployed from the needle. Desirably, the needle may beblunted while it is still in a position in the patient's stomach.Further, it is desirable that a health care provider easily detectwhether the needle has been blunted once a safety apparatus has beenactivated. Once activated, the blunting safety apparatus desirably maynot be deactivated, so that the needle could not be rendered a sharphazard again. Finally, such a blunting safety apparatus is desirablyactivated by a single-handed technique, i.e., the hand holding aproximal end of the needle, thereby allowing the health care provider'shands to remain away from a sharp distal end of the needle during suchactivation of a safety blunting apparatus.

It is also desirably to provide a method and apparatus so that theplurality of fasteners deployed in a patient's stomach do not need to beremoved via an invasive method after gastropexy. As noted, during agastropexy procedure, it is desirable to place three or four fastenersagainst a patient's stomach wall. Once a stoma is created, it isdesirable to keep the fasteners, suture and suture holder in a positionfor two to three weeks, so that the stoma becomes well stabilized, andso that gastric liquids, and so forth, do not contaminate and causeinfection in a patient's peritoneal cavity. Removing the fasteners afterthe requisite stabilization time, however, can be problematic.

Sometimes a needle apparatus is used to follow the suture back through apatient's skin to attempt to percutaneously retrieve each fastener. Sucha procedure causes new trauma, with new risks of infection.Alternatively, laproscopic methods are used to retrieve each fastener.Such a procedure often involves anesthesia, and again may cause traumain a patient's mouth, esophagus, and/or stomach.

It would be desirably to use a resorbable suture with the fastener. Sucha resorbable suture would crimp or otherwise couple to the fastener atone end, and desirably, a suture holder at an opposite end. The suturewould be absorbed by the patient's body after the critical two to threeweek period. Therefore, no invasive procedure would be required toremove the fasteners. The fasteners would fall away from a wall of thestomach, and follow a patient's digestive tract to be expelled.

The suture holder on a patient's skin is also part of the gastropexyprocedure. In some instances, a suture holder is not used, and theopposite end of the suture, which extends to the patient's skin, istemporarily stitched to the patient's skin. In other procedures, theexternal opposite end of the suture is clamped via an external retentiondevice that usually includes a cotton ball, a plastic washer, plastictubing, and one or more metal crimps. There are problems with both ofthese external suture retention methods.

Patients dislike having external stitches, which can pull against theskin, or catch on clothing or gowns. Further, additional suturingrequires additional skill and safety risks for the physician. Moreover,after external sutures are in place, there may be confusion as to whythe sutures are present. There is a risk that a health care provider, asa result of this confusion, will try to cut and pull out the externalsuture(s). Issues also exist with retention devices.

One retention device, described above, has many drawbacks. It cannoteasily be cleaned. That is, the cotton ball, which is positioned againstthe patient's skin, may easily harbor bacteria and microorganisms, andmay be difficult to change. Further, the device uses plastic tubing,washers, and metal crimps. The combination of components in thisretention device results in a high profile away from the skin, typically0.75 inches or more. These devices may pull, catch on clothing, or rubagainst the skin, causing abrasion or necrosis due to pressure.

There exists a need for a suture retention hub that has a low profileagainst a patient's skin. Such a device would be easily recognizable tohealth care provider as a retention hub for anchoring an internallydisposed device via a suture. The hub would desirably by formed from amaterial which has excellent biocompatibility and ease of cleaning. Sucha material would desirably be soft and provide cushioning against apatient's skin, to prevent abrasion and/or necrosis. Such a hub wouldpermit an adequate retention force, and desirably would permit easytensioning of the suture by a simple manipulation of the hub.

Definitions

As used herein, the term “stylus” refers to a solid or hollow rod whichhas a blunted, non-sharp distal end, which is sized to fit and movewithin and extend through at least a sharp end of a hollow needle. Thestylus is desirably, but not by way of limitation, made from the samematerial as the sharp end of the needle. However, the stylus may be madefrom any material(s) so long as it operates as shown and/or describedherein.

As used herein, the terms “comprise”, “comprises”, “comprising” andother derivatives from the root term “comprise” are intended to beopen-ended terms that specify the presence of any stated features,elements, integers, steps, or components, but do not preclude thepresence or addition of one or more other features, elements, integers,steps, components, or groups thereof. Similarly, the terms “include”,“includes”, “has” and/or “have”, and derivatives thereof, are intendedto be interpreted as the word “comprise”, and are intended to beopen-ended terms that specify the presence of any stated features,elements, integers, steps, or components, but do not preclude thepresence or addition of one or more other features, elements, integers,steps, components, or groups thereof.

As used herein, the terms “resilient”, “resilience” and/or “resiliency”and any derivatives thereof refers to the physical property of an objectand/or a material that can return to its original form, shape and/orposition after deformation such as being bent, compressed, or stretchedthat does not exceed its elastic limit.

As used herein, the term “couple” includes, but is not limited to,joining, connecting, fastening, linking, or associating two thingsintegrally or interstitially together.

As used herein, the term “configure” or “configuration”, and derivativesthereof means to design, arrange, set up, or shape with a view tospecific applications or uses. For example: a military vehicle that wasconfigured for rough terrain; configured the computer by setting thesystem's parameters.

As used herein, the terms “substantial” or “substantially” refer tosomething which is done to a great extent or degree; a significant orgreat amount; for example, as used herein “substantially” as applied to“substantially” covered means that a thing is at least 70% covered.

As used herein, the term “alignment” refers to the spatial propertypossessed by an arrangement or position of things in a straight line orin parallel lines.

As used herein, the terms “orientation” or “position” usedinterchangeably herein refer to the spatial property of a place where orway in which something is situated; for example, “the position of thehands on the clock.”

As used herein, the term “about” refers to an amount that is plus orminus ten (10) percent of a stated number or a stated or implied range.

These terms may be defined with additional language in the remainingportions of the specification.

SUMMARY OF THE INVENTION

In response to the difficulties and problems discussed herein, agastropexy kit is provided. The kit comprises a plurality of safetyneedle assemblies. Each safety needle assembly comprises a needleincluding a shaft having a sharp open distal end with a slot therein andan open proximal end. The proximal end has a needle hub thereon. Theneedle hub has an opening therethrough which is continuous with anopening provided through the shaft of the needle. The needle hubincludes at least one recess. The needle assembly also includes astylus. The stylus has a shaft including a blunt distal end and aproximal end having a stylus hub thereon. The hub of the stylus includesa retainer. The needle assembly also includes a fastener having a suturecoupled thereto. The fastener is positioned in the distal end of theneedle with the suture extending through the slot. The stylus is held ina first position when the stylus is positioned inside of the needle, andthe blunt distal end of the stylus extends a distance toward the opendistal end of the needle but is retained within the shaft of the needleby a portion of the retainer held in one recess in the needle hub. Whenthe hub of the stylus is pushed to move the blunt distal end of thestylus within the shaft of the needle, the stylus moves within the shaftand contacts the fastener therein thereby ejecting the fastener from theshaft. The blunt distal end extends beyond the sharp distal end of theneedle and the portion of the retainer is positioned in another recessin the needle hub, thereby rendering the safety needle assembly in ablunted condition, the stylus configured to non-releasably couple to theneedle to provide an unmovable position of the stylus with respect tothe needle to maintain the blunted condition. The gastropexy kit alsoincludes a suture retention hub coupled to a portion of each suture. Thesuture retention hub comprises a first base including an upper surface.The suture retention hub also includes a second base moveably coupled tothe first base, at least one of the first base and the second baseformed to include at least one aperture therethough. When the secondbase is positioned substantially at a 90 degree angle relative to theupper surface of the first base, the suture positioned through theaperture is moveable through the hub. When the second base is positionedsubstantially parallel to the upper surface of the first base, thesuture positioned through the aperture is not moveable through the hub.

In another aspect of the invention, a gastropexy kit is provided. Thekit includes a plurality of safety needle assemblies. Each safety needleassembly comprises a needle including a shaft having a sharp open distalend having a slot therein and an open proximal end. The proximal end hasa needle hub thereon. The needle hub has an opening therethrough whichis continuous with an opening provided through the shaft of the needle.The needle hub includes at least one movable stop positioned thereon.The needle hub also includes at least one recess therein. The safetyneedle assembly also includes a stylus. The stylus has a shaft includinga blunt distal end and a proximal end having a stylus hub thereon. Thehub includes an edge and a retainer. The safety needle assembly alsoincludes a fastener having a suture coupled thereto. The fastener ispositioned in the distal end of the needle with the suture extendingthrough the slot. The stylus is held in a non-deployed position when thestylus is positioned inside of the needle. The blunt distal end of thestylus extends a distance toward the open distal end of the needle butit is retained within the shaft of the needle by a portion of theretainer held in one recess in the needle hub and by a position of themovable stop against the edge. When the movable stop is moved away fromthe edge, the blunt distal end of the stylus is deployed to move withinthe shaft of the needle. The stylus moves to contact the fastener andpush the fastener out of the shaft. The distal end of the stylus extendsthrough and beyond the sharp open distal end of the needle. The portionof the retainer is moved to and positioned in another recess in theneedle hub, thereby rendering the safety needle assembly in a bluntedcondition. The stylus is configured to non-releasably couple to theneedle to provide an unmovable position of the stylus with respect tothe needle to maintain the blunted condition. The gastropexy kit alsoincludes a suture retention hub coupled to a portion of each suture. Thesuture retention hub comprises a first base formed include an openingtherein configured to hold the suture. The suture retention hub alsocomprises a second base coupled to the first base. The second base isformed to include an opening configured to hold the suture. The suturepositioned in the opening of the first base and the opening of thesecond base is moveable relative to both the first base and the secondbase when the hub is positioned in an un-locked position. The suturepositioned in the opening of the first base and the opening of thesecond base is non-moveable relative to both the first base and thesecond base when the hub is positioned in a locked position.

Additional features and advantages of the present invention will berevealed in the following detailed description. Both the foregoingsummary and the following detailed description and examples are merelyrepresentative of the invention, and are intended to provide an overviewfor understanding the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a portion of a safety needle assembly ofthe gastropexy kit of the present invention, showing the needle and itsassociated hub;

FIG. 2 is side elevational view of the portion of the safety needleassembly of FIG. 1, but showing one surface of the hub with aperturestherein;

FIG. 3 is a top plan view of the portion of the safety needle assemblyof FIG. 1, but showing another surface of the hub with grooves therein;

FIG. 4 is a sectional view of FIG. 3, taken at lines 4-4;

FIG. 5 is a perspective view of another portion of a safety needleassembly of the gastropexy kit of the present invention, showing astylus and its associated hub;

FIG. 6 is a side elevational view of the stylus and hub of FIG. 5,showing the flanges, each with a clip at a free end thereof;

FIG. 7 is a top plan view of the stylus and hub of FIG. 5, showing theflanges with clips;

FIG. 8 is an exploded perspective view of a portion of the gastropexykit, including the safety needle assembly and including a sheath;

FIG. 9 is a perspective view of the safety needle assembly of thegastropexy kit, showing the stylus positioned in at least a portion ofthe needle;

FIG. 10 is a perspective view of the safety needle assembly of thegastropexy kit positioned in the sheath;

FIG. 11 is a perspective view of the safety needle assembly of thegastropexy kit, showing the stylus extending through the needle, therebyrendering the needle blunt;

FIG. 12 is a top plan view of the safety needle assembly of thegastropexy kit, showing the stylus in the needle a T-bar fastenerpositioned therein (shown in phantom lines), a suture extending from theT-bar fastener and through the slit in the needle;

FIG. 13 is a top plan view of the safety needle assembly of thegastropexy kit, but showing the stylus extending through the needle torender the assembly in a blunted position;

FIG. 14 is a perspective view of the safety needle assembly of thegastropexy kit of FIG. 13, but shown positioned in the sheath;

FIG. 15 is a sectional view of FIG. 12, showing the clips of the flangesin the upper apertures of the needle hub; and

FIG. 16 is a sectional view similar to FIG. 13, showing the clips of theflanges in the lower apertures of the needle hub, and the blunt distalend of the stylus positioned through the distal end of the needle torender the needle assembly in a blunted position.

FIG. 17 is a perspective view of a top of a base or first base of asuture retention hub of the gastropexy kit of the present invention;

FIG. 18 is a top plan view of the base or first base of FIG. 17;

FIG. 19 is a bottom plan view of the base or first base of FIG. 1;

FIG. 20 is a sectional view of FIG. 18 taken along lines 20-20;

FIG. 21 is a perspective view of a top of a handle or second base of asuture retention hub of the gastropexy kit of the present invention;

FIG. 22 is a top plan view of the handle or second base of FIG. 21;

FIG. 23 is a bottom plan view of the handle or second base of FIG. 21;

FIG. 24 is a sectional view of FIG. 22 taken along lines 24-24;

FIG. 25 is a perspective view of a top of the suture retention hub ofthe gastropexy kit of the present invention, showing both the base orfirst base and the handle or second base;

FIG. 26 is a top plan view of the suture retention hub of FIG. 25;

FIG. 27 is a bottom plan view of the suture retention hub of FIG. 25;

FIG. 28 is an elevated side view of the suture retention hub of FIG. 25;

FIG. 29 is a sectional view of FIG. 27 taken along lines 29-29;

FIG. 30 is a sectional view similar to FIG. 29, but showing the positionof the apertures with the handle or second base positioned transverselyrelative to the base or first base, showing the alignment of theapertures in the handle or second base and the base or first base;

FIG. 31 is a sectional view similar to FIG. 29, but showing a suturepositioned through the apertures in the base or first base and thehandle or second base, showing the circuitous, crimped position of theaperture;

FIG. 32 is a sectional view similar to FIG. 30, but showing a suturepositioned through the apertures in the base or first base and thehandle or second base, showing the substantial axial alignment of thesuture in the apertures;

FIG. 33 is a perspective view of a top of a cover for the sutureretention hub;

FIG. 34 is a top plan view of the cover of FIG. 33;

FIG. 35 is a bottom plan view of the cover of FIG. 33;

FIG. 36 is a perspective view of the cover of FIG. 33, but with a sutureretention hub positioned therein;

FIG. 37 is side view of the cover of FIG. 33 with the suture retentionhub positioned therein;

FIG. 38 is a top plan view of the cover of FIG. 33 with the sutureretention hub positioned therein;

FIG. 39 is an exploded perspective view of components of the gastropexykit;

FIG. 40 is a perspective view of the components of the gastropexy kit,including the needle assembly with a fastener positioned thereon (shownin phantom lines), a resorbable suture coupled at one end to thefastener and at the opposite end to the suture retention hub, the needleassembly positioned in the sheath;

FIG. 41 is a perspective view of the needle assembly with the styluspositioned in the needle and the fastener (shown via phantom lines)positioned near a distal end of the needle, the suture coupled to thefastener extending from the slot in the needle and the suture retentionhub coupled to an opposite end of the suture;

FIG. 42 is a partial view of a patient's stomach wall, showing onedesirable deployment of fasteners, and showing a desired area forforming a tissue opening or stoma;

FIG. 43A is a side elevational view of the needle assembly positionedthrough a patient's skin and into a patient's stomach, the fastenercontained within the distal end of the needle in a non-deployed positionand the suture positioned between the fastener and the suture retentionhub on the patient's skin;

FIG. 43B is a side elevational view of the needle assembly positionedthrough a patient's skin and into a patient's stomach, the fastenerdeployed into the stomach from its previous position within the distalend of the needle, the suture positioned between the fastener and thesuture retention hub on the patient's skin;

FIG. 44A is a side elevational view with a cross-sectional view of thesuture retention hub positioned on a patient's skin and the handle ofthe hub positioned upward so that a suture is moveably positionedthrough the hub, an opposite end of the suture coupled to a fastener inthe patient's stomach;

FIG. 44B is a side elevational view with a cross-sectional view of thesuture retention hub positioned on a patient's skin and the handle ofthe hub positioned downward and generally parallel or planar to theupper surface of the hub, the suture tensioned and crimped within thehub, an opposite end of the suture coupled to a fastener in thepatient's stomach, and the hub pulling the fastener closer to thepatient's skin; and

FIG. 44C is a side elevational view of the suture retention hubpositioned on a patient's skin and the handle of the hub positioneddownward and generally parallel or planar to the upper surface of thehub, the suture tensioned and crimped within the hub, an opposite end ofthe suture coupled to a fastener in the patient's stomach, and the hubpulling the fastener closer to the patient's skin.

DETAILED DESCRIPTION

Reference will now be made in detail to one or more embodiments of theinvention, examples of which are illustrated in the drawings. Eachexample and embodiment is provided by way of explanation of theinvention, and is not meant as a limitation of the invention. Forexample, features illustrated or described as part of one embodiment maybe used with another embodiment to yield still a further embodiment. Itis intended that the invention include these and other modifications andvariations as coming within the scope and spirit of the invention.

For gastropexy, an apparatus is needed for holding and stabilizing in aposition a portion of a patient's stomach, to permit a safe and accuratepercutaneous tissue opening, namely, a stoma, into a patient's stomach.Such apparatus usually includes a needle which desirably carries asuture and fastener. An apparatus for applying tension to the suture isalso desirably used as well. The present invention describes a desirableapparatus for performing gastopexy.

Turning now to a needle apparatus of a gastropexy kit, a safety needleassembly is provided. The safety needle assembly is rendered safe bypositioning a blunt stylus therethrough, which results in blunting ofthe assembly.

Referring now to FIGS. 1-16 in general, and 1-4 in particular, thepresent invention provides a safety needle assembly 10. The safetyneedle assembly 10 includes a metal needle 12 having an opening 14extending through a metal shaft 15, which defines an inner surface 16(FIG. 4). A tapered sharp tip 17 is positioned at a distal end 18 of theneedle 12. A needle hub 20 is coupled at or near a proximal end 22 ofthe needle 12. A slot 23 may be formed desirably, but not by way oflimitation, at a lower edge 24 of the tapered distal tip 16 of theneedle 12.

A distal end 26 of the needle hub 20 is coupled about a portion of theproximal end 22 of the needle 12. The needle hub 20 includes an opening28 that is continuous with the opening 14 that extends through thehollow shaft 15 of the needle 12 and through the distal tip 16 thereof.The needle hub 20 also desirably includes opposing spaced-apart edges 29at a proximal end 40 thereof. The needle hub 20 desirably has a pair ofupper apertures or upper recesses 30, one upper recess 30 positioned oneach of the relatively flat sides 32, 34 on an outer surface 36 of thehub 20 near the proximal end 22 thereof. Another pair of lower aperturesor lower recesses 31, one lower recess 31 positioned on each of therelatively flat sides 32, 34 on an outer surface 36 of the hub 20 andnear the distal end 26 thereof. The apertures or recesses 30, 31 extendfrom the outer surface 36 to the opening 28 in the needle hub 20. Thepurpose for the apertures or recesses 30, 31 will be discussed in detailbelow.

An inner surface 37 (FIG. 4) is provided and is defined by opening 28formed through the needle hub 20. The inner surface 37 is sized toreceive a blunted stylus therethrough. The hub 20 includes a pair ofrelatively short sides 38 as well, which are spaced-apart from eachother, but are adjacent to the flat sides 32, 36. Each short side 38 hasa plurality of grooves 39 formed therein to facilitate gripping the hub20.

The needle hub 20 also includes, at the proximal end 40, a handle 42which desirably is positioned to extend away from the proximal end 40.The handle 42 desirably includes a handle shaft 44 generally axiallyaligned with the needle hub 20 and which is desirably integrally formedwith the proximal end 40 of the needle hub 20. The handle 42 alsodesirably includes a handle portion 46 which extends at an angle,desirably at about a 90 degree angle, transversely away from the handleshaft 44. A pair of wedges 47 are positioned in a spaced-apartorientation on either side of a junction of the shaft 44 and the handleportion 46. The wedges 47 are positioned to function as stops, as willbe described in further detail below. The needle hub 20 may also includea “C”-clip (not shown) to hold a suture which may be positioned at leastpartially in the needle 12.

The blunted safety needle assembly 10 also includes a stylus 50, asillustrated in FIGS. 5-7, having a solid or hollow shaft 52 sized tohave an outer surface 54 which cooperates to substantially fill adiameter of the inner surface 28 of the needle 12. The stylus 50includes a blunted, non-sharp, distal end 56 and a proximal end 58 whichis coupled to a stylus hub 60. The distal end 56 is sized and configuredto position against and move a fastener positioned near the distal tipin the shaft 15 of the needle 12.

The stylus hub 60 includes, at one end, a cylindrical upper hub 62 whichdesirably includes a standard luer lock. At an opposite end of the upperhub 62 is a narrower-diameter lower hub 64 which desirably couples aboutat least a portion of the proximal end 58 of the stylus 50. A protrudingrim or ridge 63 which extends about a circumference of the junction ofthe upper hub 62 and the lower hub 64. A pair of flanges 68 extend fromthe lower hub 64 and include free ends 72 which extend away from theupper hub 62 and toward the distal end 56 of the stylus 50, but are in asubstantial axial alignment therewith. The flanges 68 flare slightlyaway from the stylus shaft 52. Generally triangularly-shaped (in sideview) clips 74 (FIG. 6) extend outward on an outer surface 76 of eachflange 68 at each free end 72 of the flange 68. The flanges 68 and clips74 thereon provide a retainer. It will be understood that at least aportion of the stylus hub 60, that is, at least the flanges 68, is sizedto extend into and contact the inner surface 37 of the needle hub 20(FIGS. 15 and 16). The stylus 50 may include an opening 78 through hubs60, 64 and the shaft 52 of the stylus 50.

A protective sheath 80, as shown in FIGS. 8, 10 and 14, may be provided,to isolate the sharp tip 17 of the end 18 of the needle 12 and protectthe health care provider, until such time as the safety needle assembly10 is removed from the sheath 80 for use. The sheath 80 is sized to holdthe needle 12 with the stylus 50 positioned therewith. The sheath 80 hasan outer surface 82 and an inner surface 84, and is shaped generallylike a funnel having one enclosed end. The blunted safety needleassembly 10 is desirably positioned in the sheath 80, with the sharp tip17 of the distal end 18 of the needle 12 positioned in a closed end 86of the sheath 80, and the needle hub 20 and stylus hub 50 accessiblethrough an opening 88 in an open end 90 of the sheath 80. Slots 92 arepositioned adjacent the opening 88 in an opposing, spaced-apartposition. Each slot 92 is flanked by a pair of protuberances 94 formedalong an edge 96 forming each slot. When a needle assembly 10 ispositioned in the sheath 80, the edge 29 of the needle hub 20 aredesirably positioned in the slots 92 and beneath the protuberances 94.The protuberances 94 catch the rims 29 of the hub 20, thereby preventingthe needle assembly 10 from falling out of the sheath 80. In thismanner, the needle assembly 10 is releasably held in the sheath 80 untila health care provider removes the needle assembly 10 from the sheath80. Once the needle assembly 10 has been used, it may be stored in thesheath 80 (FIG. 14). It will be appreciated that the sheath 80 is formedfrom a material having resilient qualities, which permits the sheath tooperate as shown and/or described herein.

Turning now to an apparatus for applying tension to the suture, a sutureretention hub is provided, for use in performing gastropexy. The sutureretention hub desirably is used to hold a tensioning filament or sutureon an external portion of a patient's skin, and may be used to providetension to an internally disposed device via a suture. Such a device mayinclude, for example, but not by way of limitation, a “T-bar” fasteneror other fastener (not shown) which is positioned internally in apatient's stomach in a gastropexy procedure. Referring now to FIGS.17-38 in general, and 17-32 in particular, a suture retention hub 10 isillustrated. The hub 110 includes a first base or base 112 and amovable, pivotal second base or handle 114. The first base or base 112,as shown in FIG. 17-20, includes a lower surface 116 (FIG. 19) having asubstantially circular outer perimeter 18, and an upper surface 120.

A portion 122 (FIG. 19) of the perimeter 118 of the base 112 adjacentthe lower surface 116 is constructed to have a flat wheel or disk-likeappearance. A bar 124 is provided and extends across the lower surface116 from perimeter 118 to perimeter 118 of the base 112. The bar 124 hasan opening 125 which extends therethrough which defines an inner surface126. The bar 124 also has an aperture 128 formed transverselytherethrough. On one side of the bar 124, an indentation 130 is providedbetween the bar 124 and the perimeter 118 of the base 112 on the lowersurface 116. On the opposite side of the bar 124, an opening 132 extendsbetween the bar 124 and the perimeter 118. The opening 132 extends fromthe lower surface 116 through the upper surface 120 of the base 112.

An outer portion of the upper surface 120 of the base 112 generally hasa circular perimeter and the upper surface 120 includes a semi-circularraised flat surface 134. The opening 128 through the base 112 isgenerally, for example, desirably generally semi-circular inconfiguration, being defined between a portion of the perimeter 118 andthe bar 124. An edge 135 of the perimeter 118 is adjacent the opening128, and provides an L-shaped flange 136 along a portion of theperimeter 118 on the upper surface 120. The L-shaped flange 136 includesan opening 137 therein.

The pivotal second base or handle 114, as illustrated in FIGS. 21-24,couples to the base 112 via a pivot pin 138. The pivotal second base orhandle 114 is also of a generally semi-circular configuration, andincludes a pivot pin 138 having a boss 140 at a free end thereof. Thepivot pin 138 and boss 144 are in an axial alignment with an opposing,spaced-apart boss 144 formed on a portion of the second base or handle114. The pivot pin 138 has an aperture 146 formed therethrough. Theaperture 146 may be generally in an axial alignment with the aperture128 positioned transversely through the bar 124 of the base 112 when thesecond base or handle 114 is pivoted into a transverse position relativeto the upper surface 120 of the base 112.

The second base or handle 114 includes a perimeter 147 and an uppersurface 148 which desirably includes a lip 150 formed to include a smallopening 152 therein. On a lower surface 154 of the second base or handle114, an inner edge 156 of the perimeter 147 includes a knob 158positioned thereon. The second base or handle 114 is formed from amaterial which has some resiliency. Therefore, at least portions of thesecond base or handle 114 may resiliently bend to permit assembly withthe base 112. When assembled, the pivot pin 138 of the second base orhandle 114 is positioned in the opening 125 of the bar 124 of the base112 (FIG. 29). The second base or handle 114 is moveable or pivotablewith respect to the base 112 when in an opened position (FIG. 30). Thesecond base or handle 114 is frictionally held in a non-pivotingposition when the second base or handle 114 is positioned against theflange 136 and the knob 158 is positioned through the opening 137 of theflange 136. The knob 158 and the opening 137 cooperate to provide alatch assembly for locking and un-locking the hub 110, therebypositioning and holding the second base or handle 114 in a lockedposition (FIG. 29) relative to the base 112. In this position, theaperture 146 formed through the pivot pin 138 is moved out of itsgeneral axial alignment (which occurs when the second base or handle 114is positioned transversely at a about a 90 degree angle relative to theupper surface 120 of the first base or base 112). That is, the aperture146 positioned through the pivot pin 138, in the locked position, ispositioned at about a 90 degree angle with respect to the aperture 128in the bar 124 of the first base or base 112.

The hub 110 may include a soft outer cover 160, as illustrated in FIGS.33-38. The cover 160 is desirably, but not by way of limitation, a onepiece cover 160 that is soft and has some resiliency to allow it tostretch to fit over the hub 110. Such a soft outer cover may beconstructed from, for example, but not by way of limitation, a medicalgrade thermoplastic polyurethane. This type of material is desirablyused to disburse the pressure from tension on the hub 110 against apatient's skin, thereby reducing the possibility of the hub 110 causingthe development of a pressure sore or necrosis occurring under the hub110.

The cover 160 desirably is generally disk-shaped, with a lower outersurface 162, an outer perimeter 164 and an upper outer surface 166. Thecover 160 may desirably include an opening 168 and a flap 170 formedadjacent the opening 168. The hub 110 is desirably positioned throughthe opening 168 and the lower surface 116 of the base 112 of the hub 110is positioned against an inner surface 172 and adjacent the lowersurface 162 of the cover 160. The hub 110 may be substantiallyencompassed by the cover 160. The hub 110 is positioned such that thesecond base or handle 114 is desirably positioned adjacent the opening168 in the upper surface 166 of the cover 160. The cover 160 includes anaperture 174 positioned through the lower surface 162 and a slit 176positioned through the flap 170 of the upper surface 166 of the cover160. The aperture 174 and the end of the slit 176 of the cover 160 aredesirably generally aligned with the aperture 128 positioned through thebar 124 of the base 112.

Desirably a suture 96 is positioned through the aperture 128 in the bar124 of the base 112, and through the aperture 146 of the pivot pin 138of the second base or handle 114, as shown in FIGS. 31 and 32. Thesuture 96 is also positioned through the aperture 174 and the slit 176in the cover 160 (not shown).

When it is desired to pull a portion of the suture 96 through the hub110, as illustrated in FIG. 32, the suture 96 moves relatively easilythrough the hub 110 when the hub 110 is in an un-locked position. Thatis, the suture 96 passes through the aperture 128 in the bar 124 and theaperture 146 in the pivot pin 138, when the second base or handle 114 ispositioned at an angle, desirably at substantially a 90 degree angle,relative to the upper surface of the base 112. In this position, theaperture 146 in the pivot pin 138 of the second base or handle 114 andthe aperture 128 in the bar 124 of the base 112 are in a substantiallyaxial alignment. Further, the aperture 174 and slit 176 in the cover 160are also in a substantially axial alignment.

When it is desired to hold the suture 96 in its position in the hub 110,the hub 110 may prevent movement of the suture 96 and frictionally crimpthe suture in an unmovable position when the hub 110 is positioned in alocked position, as shown in FIG. 31. That is, the when the second baseof handle 114 is positioned substantially parallel or planar to theupper surface 120 of the base or first base 112, the suture 96 isprevented from moving. This is due to the aperture 146 in the pivot pin138. Therefore, the suture 96 therein is positioned at an angle, anddesirably substantially a 90 degree angle, relative to the aperture 128in the bar 124 in the first base or base 112 and the suture 96positioned therein, and may crimp the suture 96 against the innersurface 126 of the bar 124 as well.

For example, when the suture 96 is to be tensioned, the suture 96 is notmovable relative to the hub 110 when the second base or handle 114 ispositioned in the closed, locked position. The suture 96 greatly resistspressure to move through the hub 110 when positioned in this frictional,crimped, non-aligned position, which essentially locks the suture 96 ina non-moveable position against a device, such as a fastener 95, whichmay be positioned on the opposite end of the suture 96. That is, the hub110 will hold the suture 96 in a position until an excess of 3 pounds ofpressure is applied to the suture 96.

In a method of use of the gastropexy kit, a plurality of safety needlesassemblies, each having a fastener loaded therein, each fastener coupledto a resorbable suture, are provided. Each resorbable suture desirably,at an opposite end, is moveably coupled to a suture retention hub. FIG.42 illustrates a section of a patient's stomach wall 99 after four T-barfasteners 95 are positioned thereon. The “+” in the center of the fourT-bar fasteners 95 represents the area where a tissue opening, or stoma,will be made (not shown).

Turning now to the preparation of the safety needle assembly, and asshown generally in FIGS. 8-16 and 39-41, the stylus 50 is inserted intothe hollow needle 12 by introducing the blunted distal end 56 of thestylus 50 into the opening 28 at the proximal end 40 of the needle hub20. The shaft 52 of the stylus 50 is positioned through the opening 28of the needle hub 20 and through the opening 14 of the shaft 15 of theneedle, such that the outer surface 54 of the stylus contacts the innersurface 16 of the needle 12 and a portion of the outer surface 54 of thestylus hub 60 contacts the inner surface 38 of the needle hub 20.

The stylus hub 60 is desirably aligned with the needle hub 20 duringthis process, so that the retainer, that is, the flanges 68 of thestylus hub 50 and the clips 74 thereon are oriented to align with andmove into the upper apertures or upper recesses 30 in the needle hub 20.In such an orientation, the ring or protruding edge 63 on the outercircumference of the upper hub 62 contacts the wedges 47 on the shaft 44of the handle 42. The wedges 47 act as stops, to prevent the movement ofthe stylus hub 60 and stylus 50 toward the distal end 18 of the needle12. Such action is necessary so that the stylus 50 is not inadvertentlypushed to move into and through the needle 12, wherein the end 56 of thestylus moves through the distal tip 17 of the needle 12 to blunt theneedle assembly 10. Therefore, the handle 42 and wedges 47 thereoncooperate to hold the safety needle assembly 10 in a stable butun-blunted, non-deployed position. If the safety needle assembly iscontained within a sheath 80, it is removed therethrom at this time.

It will be appreciated that a substance, such as, for example only, aradio-opaque substance may be loaded into the shaft 15 of the needle 12prior to, or after, the introduction of the stylus 50 therein. Asillustrated in FIGS. 40, 41, 43A and 43B, a fastener 95, for example, a“T-bar” fastener, which is a small cylindrical element which is sizedand configured to fit within the distal end 18 and into the shaft 15 ofthe needle 12 is loaded into the distal end 18 and positioned in theshaft 15. The suture 96 on the fastener 95 is positioned to protrudefrom the slot 23 in the distal end 18 of the needle 12. The fastener 95may also be positioned in the shaft 15 of the needle 12 prior to, orafter, the introduction of the stylus 50 therein. The “bar” portion ofthe T-bar fastener 95 is desirably moved proximally in the shaft 15, atleast enough so that it does not extend into the opening 14 at thedistal end 18 of the needle 12. The remainder of the suture 96 mayextend proximally, toward the needle hub 20 and may be releasably heldby the hub 20 by passing the suture 96 through a the clip, such as a “C”clip (not shown) on the hub 20. The suture retention hub 110 isdesirably positioned on or near an opposite end of the suture 96. Eachsafety needle assembly is desirably held in a sheath 80 until removedtherefrom by a health care provider for use (FIG. 40).

The needle assembly 10 is desirably removed from the sheath 80, as shownin FIG. 41, and a health care provider may introduce the needle 12 ofthe assembly 10 through a patient's skin 97 and abdominal wall into apatient's stomach 98, as shown in FIG. 43A. The stylus 50, after thesafety needle assembly 10 has been inserted into the stomach, desirablyacts to deploy the T-bar fastener 95 and a portion of the suture 96,into the patient's stomach 98.

Once the needle 12 has been moved to a desired depth so that, forexample, the distal end 18 of the needle is positioned in a patient'sstomach, the stylus 50 is desirably activated by a health care provider.The provider moves the handle 42 and wedges 47 away from the needle hub20 by pushing the handle portion 46 downward, thereby positioning thehandle 42 in a transverse orientation relative to the needle assembly10. The handle 42 may desirably, but not by way of limitation, besnapped off and removed from the needle hub 20. The stylus hub 60 isthen pushed so that it moves toward the distal end 18 of the needle 12.This action pushes the blunt distal end 56 of the stylus 50 through theshaft 15 of the needle 12 such that the blunt distal end 56 contacts thefastener 95 and pushes or moves it out of the shaft 15 and out of thedistal end 18 of the needle 12, as illustrated in FIG. 43B. It will beappreciated that any substance, such as a radio-opaque substance,contained within the shaft 15 of the needle 12 is similarly moved out ofthe shaft 15 and disposed out with the needle 12 (not shown).

Moving the stylus 50 within the needle 12 acts to position the needleassembly 10 in a blunted position, even while the needle assembly 10 ispositioned in a patient's stomach 98. As the stylus 50 is moved towardthe distal end 18 of the needle 12, the retainer, namely, the clips 76on the flanges 68, move out of the upper apertures or upper recesses 30in the needle hub 20, which act to hold the stylus 50 to the needle 12and continue in a movement toward the distal end of the needle hub 20such that the clips 74 move into the lower apertures or lower recesses31 of the needle hub 20. In this position, the retainer via the clips 76act to lock the stylus 50 into a non-releaseable locked positionrelative to the needle 12. Therefore, the safety needle assembly 10 isplaced in a stable, blunted position which cannot be altered; the clips76 cannot be removed from the lower apertures 31 once they arepositioned in them. In this blunted position, the safety needle assembly10 is positioned in a permanently blunted position, and the safetyneedle assembly 10 is not useable again, and must be disposed of.

Once the fastener 95 has been deployed via the needle assembly 10, thesuture retention hub 110 is desirably operated to move the fastener 95in a position against a wall 99 of a patient's stomach 98 and to movethe stomach wall 98 more closely to a patient's skin 97 and to secureit.

In a method of use of the present invention, the suture retention hub110 is coupled to the suture, desirably a resorbable suture 96. Thesuture 96 is desirably tensioned so that the fastener 95 is movedcloser, and desirably adjacent, the patient's stomach wall 99, as shownin FIG. 44A, by applying tension on the suture 96 until it cannot bepulled further through the opening made by the needle 12. The sutureretention hub 110 is desirably positioned such that the second base orhandle 114 is positioned transversely at about a 90 degree anglerelative to the upper surface 120 of the first base or base 112 of thehub 110, which is desirably positioned in the cover 160 (shown best inFIGS. 36 and 37). In this position, the suture 96 is substantiallyaxially aligned through the various components of the hub 110, and thesuture 96 moves freely through the aperture 128 in the bar 124 of thefirst base or base 112 and through the aperture 146 in the pivot pin 138of the second base or handle 114, as shown in FIG. 32 and FIG. 44A. Thismovement allows a health care provider to adjust the hub 110 against thepatient's skin 97 and apply tension between the fastener 95 and the hub110 via the suture 96. Once sufficient tension has been applied, theposition of the suture 96 in the hub 110 is locked via the latchassembly of the hub 110. This locked position crimps the suture 96 andprohibits movement of the suture 96 within the hub 110, so that thetension will remain constant. That is, the second base or handle 114 ismoved or pivoted so that it is substantially parallel or planar to theupper surface 120 of the base or first base 112, as illustrated in FIG.31 and FIGS. 44B and C.

To mechanically lock the hub into this position, the second base orhandle 114 is pivoted to rest against the flange 136 at the edge 135 ofthe first base or base 112, and the latch assembly, the knob 158 on theinner edge 156 of the second base or handle 114 is positioned throughthe opening 137 in the flange 136, thereby positioning the second baseor handle 114 in the locked position. In this position, as previouslydescribed herein, the suture 96 in the aperture 146 of the pivot pin 138of the second base or handle 114 is rotated at about a 90 degree angleaway from its previous substantially axial alignment with a portion ofthe suture 96 in the aperture 128 in the bar 124 of the first base 112.This rotation also serves to frictionally crimp or hold the suture 96between an outer surface 188 of the pivot pin 138 and the inner surface126 of the bar 124.

The suture 96 may then be knotted on the upper surface 166 of the cover160, if desired (not shown). In the locked position, the suture 96 inthe hub 110 is positioned in a circuitous, crimped “Z” or “S”configuration (FIGS. 31 and 44B).

While it is possible to un-latch the second base or handle 114 from itslocked position on the first base or base 112, in many procedures, itwould be undesirable to do so. The lip 150 of the upper surface 148 ofthe second base or handle 114 may be moved upward, thereby moving theknob 158 out of the opening 137 in the flange 136 thereby un-locking thesuture 96 in the hub 110. Such a procedure may relax tension on thesuture 96, depending upon the angle upon which the second base or handle114 is positioned.

By using a resorbable suture, which is constructed to dissolve after thecritical two to three week period required to stabilize the wall of thestomach and tissue opening or stoma created therein (not shown), nofurther invasive techniques are required to remove the fastener. Whenthe suture is absorbed, the fastener will move through the patient'sdigestive tract and be expelled. The suture retention hub will also bereleased once the suture is absorbed.

The needle 12 is desirably constructed from stainless steel, and may bean 18 gauge thin wall needle. The needle hub 20 is desirably constructedfrom plastic, and more desirably is a medical grade polycarbonate,medical grade macrolon, or the like. The needle tip may desirably be anon-coring needle tip, and may have a double bevel with reverse grind atthe tip. The stylus 50 is desirably also constructed from stainlesssteel, and may be a 20 gauge thin wall hypodermic tube having a blunted,smooth distal end. The stylus hub 60 is desirably constructed fromplastic, and more desirably is a medical grade polycarbonate, medicalgrade macrolon, or the like. It will be understood, however, that thatany portion of the safety needle assembly 10, including the sheath 80,may be constructed from any material or combination of materials, in anygauge or thickness, with any variations, so long as the safety needleassembly 10 operates as shown and/or described herein.

The base 112 of the suture retention hub 110 is desirably constructedfrom a medical grade polycarbonate. The second base or handle 114 of thehub 110 is desirably constructed from a medical grade polypropylene. Thecover 160 of the hub 10 is desirably constructed from a medical gradethermoplastic polyurethane. It will be appreciated, however, that anycomponent of the hub 110 may be constructed from any medicallyacceptable material(s), so long as the hub 110 operate as shown and/ordescribed herein.

It is desirable that the hub 110 provide a low, flat profile, toincrease comfort and decrease the chance of inadvertently hooking thehub 110 on clothing, other devices, and so forth. The height dimension190 of the hub 110 is desirably in a range of about 0.08 to about 0.140inches. Even more desirably, the height dimension of the hub 110 is in arange of about 0.09 to about 0.13 inches. Most desirably, the heightdimension of the hub 110 is in a range of about 0.100 to about 0.120inches. When the hub 110 is positioned in the cover, the heightdimension is desirably in a range of about 0.150 to about 0.250 inches.Even more desirably, the height dimension of the hub 110 in the cover isabout 0.175 to about 0.225 inches. Most desirably, the height dimensionof the hub 110 in the cover 160 is about 0.190 to about 0.210 inches.

The hub 110 is desirably wider than its height dimension. Therefore, thehub 110 desirably has a width dimension 192, which includes the cover160, in a range of about 0.450 to about 0.700. Even more desirably, thewidth dimension of the hub 110 in the cover 160 is in a range of about0.048 to about 0.675 inches. Most desirably, the width dimension of theof the hub 110 in the cover 160 is about 0.500 to about 0.650 inches.

The diameter of the aperture 128 through the bar 124 of the first baseor base 112, the diameter of the aperture 146 through the pivot pin 138of the second base or handle 114, the diameter of the aperture 174 andthe end diameter of the slit 176 in the cover 160 are each desirably ina range of about 0.024 to about 0.026 inches. More desirably, thediameter of the apertures 128, 146, 174 and end of slit 176 are about0.025 inches.

It will be appreciated that the first base or base 112 and/or the secondbase or handle 114 may not include apertures therethrough for the suture(not shown). In this alternative, a suture may extend into an opening inthe bar of the base, and may be crimped by the rotation of the pivotpin. In this embodiment, the pivot pin may, but not by way oflimitation, contain a bump, knob, and so forth, to create a frictionalresistance between the pivot pin and the inner surface of the bar (notshown). In other alternatives, only one opening only through the base112 may be utilized (not shown). In other alternatives, only one openingthrough the handle 114 may be utilized (not shown).

The configuration of any component(s) shown or described herein isintended as non-limiting. That is, no component is intended to belimited to a single configuration. Any configuration(s) of anycomponent(s) which permit the component and gastropexy kit to operate asshown and/or described herein may be used.

While the present invention has been described in connection withcertain preferred embodiments, it is to be understood that the subjectmatter encompassed by way of the present invention is not to be limitedto those specific embodiments. On the contrary, it will be appreciatedthat some elements and/or articles may be used with other elements orarticles. It is intended for the subject matter of the invention toinclude all alternatives, modifications and equivalents as can beincluded within the spirit and scope of the invention.

1. A gastropexy kit, comprising: a plurality of hollow safety needleassemblies used in the percutaneous fixation of a hollow organ, eachsafety needle assembly comprising: a needle including: a needle shafthaving a sharp open distal end with a slot therein and an open proximalend, the needle shaft being configured to hold an object in the distalend of the needle, and a needle hub at the proximal end of the needleshaft, the needle hub having an opening therethrough which is continuouswith an opening provided through the shaft of the needle, the needle hubincluding at least a first recess and a second recess thereon; a stylusincluding: a stylus shaft including a blunt distal end and a proximalend, and a stylus hub at the proximal end of the stylus shaft, thestylus hub including at least one retainer which extends a distance awayfrom the stylus such that, when the stylus shaft is positioned inside ofthe needle shaft, the blunt distal end of the stylus shaft extends adistance toward the open distal end of the needle shaft and, when thestylus hub is positioned inside the needle hub, the retainer ispositioned such that at least a portion of the retainer exerts atransverse pressure on an inner surface of the needle hub causingresistance to axial movement of the stylus shaft; and a fastener havinga suture coupled thereto, the fastener positioned in the distal end ofthe needle shaft with the suture extending through the slot; wherein thestylus shaft is held in a first position when the portion of theretainer is positioned in the first recess of the needle hub such thatthe blunt distal end of the stylus resists movement toward the opendistal end of the needle and is retained within the shaft of the needle,and when the stylus hub is pushed to move the blunt distal end of thestylus through and beyond the sharp open distal end of the needle shaft,the stylus moves within the shaft and contacts the fastener thereinthereby ejecting the fastener from the shaft such that the blunt distalend extends beyond the sharp distal end of the needle and the portion ofthe retainer is positioned in the second recess in the needle hub,thereby rendering the safety needle assembly in a blunted condition, thestylus configured to non-releasably couple to the needle to provide anunmovable position of the stylus with respect to the needle to maintainthe blunted condition; and a suture retention hub coupled to a portionof each suture, the suture retention hub comprising: a base including abar, the bar having an opening formed therethrough configured tomoveably hold a portion of a handle within at least a portion of thebase, the base formed to include an aperture therethrough; and a handleconfigured to moveably fit within at least a portion of the base, aportion of the handle having an aperture formed therethough, the portionof the handle positioned within the portion of the base to permitmovement of the handle; wherein the aperture in the base and theaperture in the handle are substantially in an axial alignment when thehandle is positioned transversely relative to an upper surface of thebase such that a suture positioned therethrough moves readily throughthe apertures, and wherein the aperture in the base and the aperture inthe handle are substantially out of an axial alignment when an uppersurface of the handle is positioned in a parallel alignment relative tothe upper surface of the base such that a suture positioned therethroughis frictionally crimped in its position in the handle and the base,thereby preventing movement of the suture within the suture retentionhub.
 2. The gastropexy kit of claim 1, wherein the needle furtherincludes a movable stop at a proximal end of the needle hub, the movablestop comprising a handle having a stop positioned thereon and the stylusfurther includes a stylus edge at a proximal end of the stylus hub, thestylus edge comprising a protruding rim or ridge.
 3. The gastropexy kitof claim 2, wherein when the stop on the handle is positioned againstthe edge of the stylus, the stylus is held in a position preventingmovement toward the distal end of the needle.
 4. The gastropexy kit ofclaim 3, wherein when the handle is moved such that the stop is movedaway from the edge of the stylus, the blunt distal end of the stylusshaft is movable to extend through and beyond the sharp open distal endof the needle shaft thereby rendering the safety needle assembly in ablunted condition.
 5. The gastropexy kit of claim 2, wherein the handlebreaks away from the needle hub.
 6. The gastropexy kit of claim 1,wherein the portion of the retainer includes a clip.
 7. The gastropexykit of claim 6, wherein the clip of the retainer is positioned into thefirst recess of the needle hub to assist the stop in holding the stylusin a non-deployed position.
 8. The gastropexy kit of claim 7, whereinwhen the movable stop is moved away from the portion of the stylus, theblunt distal end of the stylus shaft is movable to extend through andbeyond the sharp open distal end of the needle shaft and the retainer ismoved such that the clip of the retainer is positioned into the secondrecess of the needle hub, and the stylus shaft extends through andbeyond the distal end of the needle shaft in a deployed position and torender the stylus in an unmoveable position such that the needleassembly is maintained in a safe blunted condition.
 9. The gastropexykit of claim 1, wherein the handle is formed from a resilient material,and the handle resiliently bends to pivotably couple to the base of thehub.
 10. The gastropexy kit of claim 1, wherein the suture retention hubincludes a cover, and the cover extends at least over the lower surfaceof the suture retention hub, and is formed of a relatively softmaterial.
 11. The gastropexy kit of claim 1, wherein the width dimensionof the suture retention hub is greater than the height dimension of thesuture retention hub.
 12. The gastropexy kit of claim 1, wherein thesuture is resorbable.
 13. A gastropexy kit, comprising: a plurality ofhollow safety needle assemblies used in the percutaneous fixation of ahollow organ, each safety needle assembly comprising: a needleincluding: a needle shaft having a sharp open distal end having a slottherein and an open proximal end, the needle shaft being configured tohold an object in the distal end of the needle, a needle hub at theproximal end of the needle shaft, the needle hub having an openingtherethrough which is continuous with an opening provided through theneedle shaft, the needle hub including at least a first recess and asecond recess therein, a movable stop at a proximal end of the needlehub, the movable stop comprising a handle and a stop; and a stylusincluding: a stylus shaft including a blunt distal end, a stylus hub atthe proximal end of the stylus shaft, the stylus hub including at leastone retainer which extends a distance away from the stylus shaft, and astylus edge at a proximal end of the stylus hub, the stylus edgecomprising a protruding rim or ridge; a fastener having a suture coupledthereto, the fastener positioned in the distal end of the needle shaftwith the suture extending through the slot; wherein the safety needleassembly is configured to move from a non-deployed position in which:the stylus hub is positioned inside of the needle hub such that theblunt distal end of the stylus shaft extends a distance toward the opendistal end of the needle shaft but is retained within the needle shaftby a portion of the retainer positioned in the first recess in theneedle hub ,and the movable stop is positioned against the stylus edgeat the proximal end of the stylus hub and the retainer is positionedsuch that at least the portion of the retainer exerts a transversepressure on an inner surface of the needle hub resulting in resistanceto axially movement of the stylus, to a deployed position in which: themovable stop is moved away from the stylus edge, at the proximal end ofthe stylus hub so that the blunt distal end of the stylus is moved in adistal direction within the needle shaft to contact the fastener andpush the fastener out of the shaft, and the blunt distal end of thestylus extends through and beyond the sharp open distal end of theneedle, and the portion of the retainer is moved to and positioned inthe second recess in the needle hub, thereby locking the needle andstylus together in a fixed position and the safety needle assembly isrendered in a blunted condition; and a suture retention hub coupled to aportion of each suture, the suture retention hub comprising: a firstbase including an upper surface; and a second base moveably coupled tothe first base, at least one of the first base and the second baseformed to include at least one aperture therethough; wherein when thesecond base is positioned substantially at a 90 degree angle relative tothe upper surface of the first base, a suture positioned through theaperture is moveable through the suture retention hub, and wherein whenthe second base is positioned substantially parallel to the uppersurface of the first base, a suture positioned through the aperture isnot moveable through the suture retention hub.
 14. The gastropexy kit ofclaim 13, wherein the portion of the retainer includes a clip, andwherein the clip of the retainer is positioned into the first recess ofthe needle hub to assist the stop in holding the stylus in thenon-deployed position.
 15. The gastropexy kit of claim 14, wherein whenthe movable stop is moved away from the portion of the stylus, the bluntdistal end of the stylus shaft is movable to extend through and beyondthe sharp open distal end of the needle shaft and the retainer is movedsuch that the clip of the retainer is positioned into the second recessof the needle hub, and the stylus shaft extends through and beyond thedistal end of the needle shaft in a deployed position and to render thestylus in an unmovable position such that the needle assembly ismaintained in a safe blunted condition.
 16. The gastropexy kit of claim13, wherein the width dimension of the suture retention hub is greaterthan the height dimension of the suture retention hub.
 17. Thegastropexy kit of claim 13, wherein the suture positioned in the openingin the first base and the opening in the second base is positioned in asubstantially axial alignment in its position in the suture retentionhub when the second base is positioned transversely relative to an uppersurface of the first base, and the suture moves readily through thesuture retention hub when it is in its un-locked position.
 18. Thegastropexy kit of claim 16, wherein the suture is positioned in theopening in the first base and the opening in the second base ispositioned substantially out of axial alignment in its position in thesuture retention hub when the second base is positioned about parallelrelative to the upper surface of the first base, and the suture iscrimped into an unmovable position in the suture retention hub when itis in its locked position.